Replies to post #84918 on NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

In this abstract conclusion:

http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=eae2d342-dd5a-41ba-9eb4-63990d3122b8&cKey=b3f9854e-1315-4bb3-bc0a-f513119c3371&mKey=%7b19573A54-AE8F-4E00-9C23-BD6D62268424%7d

A second cohort of patients with rGBM consisted of 8 patients with recurrence following several adjuvant temozolomide treatment cycles. Median OS for these patients is 14.7 months from the time of surgery for first recurrence. The comparator for this cohort is derived from Friedman et al. (2009), who reported mOS of 8.7-9.3 months from the time of first recurrence for rGBM patients treated with Bevacizumab with or without Irinotecan.

Results and Conclusion These results suggest that treatment with DCVax-L can extend survival by 5 months or more in patients with rGBM.

Those 8-patients were enrolled as recurrence GBM patients in the Phase I/II. The patients had progressed on their newly diagnosed GBM standard of care treatment. They underwent a second surgical resection. They were not immediately treated with the vaccine at the time of "recurrence" surgery. Instead, if you read the study's accompanying paper, you would find that they received their very first vaccination many months later after recovering from surgery and being tapered off steroids. The vaccine needed to be made for the patients from recurrent surgery. The Phase I/II those 8-patient wait time between "recurrence" surgery and first injection day "0" and that ranged from 7 - 30 weeks.

If you were to calculate the median OS for those 8-patients who were on DCVax-L therapy for recurrence GBM it would be closer to 11 months. If you add those patients median Time to Treatment (TTT), which is median time between first recurrent surgery and injection day 0, the median OS from the first recurrence surgery rises to 14.7 months median OS.

Understand that we were never given the exact TTT, on each of the 8-patients, so no skeptic has the ability to determine if the mOS for FIRST RECURRENT SURGERY reported is right or wrong. The scientist only gave us this information below on the TTT, thus we need to take them at their word on the abstract median OS:

Recurrent glioblastoma patients had previous radiation therapy and chemotherapy prior to presenting with tumor recurrence, so they underwent surgical resection of their tumors followed by DC immunotherapy after they had recovered from surgery and were tapered off peri-operative steroids. This ranged from 7–30 weeks after surgery.

Those 8-patients needed time to get their Dendritic Cells to make their recurrent DCVax-L vaccine. That 7-30 weeks TTT delay is quite a bit of time for the recurrent tumor, which initially failed standard of care, had to grow. Imagine that cutting down on that median "TTT" delay will improve median OS survival in Placebo patients when calculating OS from the vaccine's first injection date.

In this Phase III the crossover TTT needs to be less than 3 months. In this Phase III trial the crossover patient will not be eligible for their vaccine if they are unable to begin their dosing 12 weeks after their recorded recurrent date. In the prior Phase I/II, in the recurrence setting at least 1 of the 8 patient waited 7 months after their "first recurrence" surgery to receive their first injection. In this Phase III the progression patients will not need to go through leukapheresis at the time of recurrence. The patients' vaccine will be ready to be given to the patients once progression is established provided the patients are well enough to receive it. And as we all know, the less "wait time" that the patients do before starting crossover therapy, the more likely the tumor load is smaller upon initiating therapy. If folks want to understand why the DCVax-L therapy is doing better than even they anticipated this removal of treatment delay will be one of the reasons why.